Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia

A Phase IV Study of Corticosteroids As Prophylaxis for Infusion-Related Adverse Events to Mylotarg® in Patients With Acute Myelogenous Leukemia (AML)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00304447

Enrollment

Registered

2006-03-17

Start date

2002-04-30

Completion date

2004-01-31

Last updated

2009-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infusions, Intravenous, Leukemia, Myelocytic, Acute

Keywords

Leukemia, Mylotarg, Safety, Adverse Events

Brief summary

The purpose of this study is to evaluate the effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events, to evaluate the effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelet recovery (CRp) at one-month post treatment.

Interventions

DRUGMylotarg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with CD33 positive, resistant or relapsed AML. * Patients \> 18 years of age. * ECOG performance status 0-2.

Exclusion criteria

* Fever (\>38), chills or hypotension (systolic BP\<105mmHg) in the 48 hours preceding therapy. * Use of corticosteroids, diphenhydramine or acetaminophen within 24 hours of enrollment. * Participation in any other Mylotarg® protocol.

Design outcomes

Primary

Measure	Time frame
The effect of corticosteroids on the frequency and severity of Mylotarg® infusion-related adverse events.	—

Secondary

Measure	Time frame
The effect of corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete response with incomplete platelets recovery (CRp) at one-month post treatment.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026